Nipro Renal Soultions USA, Corporation: Device Recall
Recall #Z-1730-2025 · 04/11/2025
Class I: Dangerous
Recall Details
- Recall Number
- Z-1730-2025
- Classification
- Class I
- Product Type
- Device
- Recalling Firm
- Nipro Renal Soultions USA, Corporation
- Status
- Ongoing
- Date Initiated
- 04/11/2025
- Location
- Lewisberry, PA, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 816,840 units (BC+201), 39,228 units (BC+100)
Reason for Recall
Potential for the presence of visible foreign matter.
Product Description
MedicaLyte Liquid Bicarbonate Concentrate. Model Numbers: BC+201 (45X), BC+100 36.83X. Plastic bottle packaged in corrugated shipper cases (4 bottles per shipper case).
Distribution Pattern
US Nationwide distribution in the states of AZ, CA, CO, DE, FL, GA, IL, KS, LA, MA, MI, MN, MO, NC, NJ, NV, NY, OH, OK, OR, PA, SC, TX, UT, VA, WA, PR. International distribution to Guatemala and Panama.
Other Recalls by Nipro Renal Soultions USA, Corporation
- Class II: Risk 11/22/2024
View all recalls by Nipro Renal Soultions USA, Corporation →
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.